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Subject Matter Expert Mass Spectrometry Job Netherlands,  

MSD (company)


Posted on : 10 April 2017

Project Description


About Us:
  • Our company  is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. 
  • Today, we are building a new kind of healthcare company  one that is ready to help create a healthier future for all of us. 
  • Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. 
  • To this end, we strive to create an environment of mutual respect, encouragement and teamwork.
  •  As part of our global team, you ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.



The department
  • The Global Vaccines and Biologics Commercialization (GVBC) supports the commercialization of vaccines and biotechnological derived pipeline products. 
  • Furthermore, GVBC has a crucial role in supporting vaccines and biologics Lines of Business (LoB) and the Quality Organization.
  •  As part of the GVBC organization analytical and process Centers of Excellence are located in the US. 
  • These teams are regionally responsible for support to LoB and Quality and introducing new processes and analytical methods into the commercial operations space.



The position
  • Reporting into the Team Lead SME s the Subject Matter Expert Mass Spectrometry holds a Subject Matter Expert (SME) role for mass spectrometry analysis.
  •  The individual oversees all mass spectrometry efforts from a scientific perspective and is able to translate current thinking and new advances into our analytical portfolio.
  •  In that role the person establishes and maintains an internal and external network of mass spectrometry experts.
  •  Furthermore he or she indirectly guides all mass spectrometry related activities in the department and provides significant input into regulatory documents and response to questions. 
  • This position does not have direct reports.



Roles and responsibilities include:
Scientific and Technical leadership (60% of average time spent)
  • Analytical SME, with deep scientific understanding of all mass spectrometry methods used for characterizing biotechnological products;
  • Responsible for best scientific practices within the lab space and supports from an extended characterization perspective troubleshooting, process support and life cycle management activities;
  • Writes complex technical documentation used for regulatory filings (e.g. Justification of specifications, process characterization summaries);
  •  Recruitment and supervision of MSc-level students.



Project leadership (40% of average time spent)
  • Participates in cross-functional/global CMC project teams and leads derived subteams (e.g. working groups responsible for analytical or drug substance development workstreams);
  • Participates as SME in solving technical problems at an international level;
  • Root Cause Analysis lead for significant investigations (regional).



Qualifications
  • PhD in biological sciences, biochemistry, or biochemical engineering or equivalent through experience;
  • Minimum of 5-10 years relevant experience in protein analytics;
  • Significant experience in analytical methodologies for quality control of biotechnological products;
  • Strong project management skills & proven ability to manage complex projects;
  • Knowledge of regulatory and quality guidelines, and knowledge on CTD format for IND/ BLA/ MAA submissions preferred;
  • Excellent analytical and technical skills;
  • Demonstrated initiative, and innovative process-oriented thinking within a team environment;
  • Strong oral and written communication skills in English (required), Dutch or willing to learn Dutch is a plus.



A good place to work
  • Our employees are the key to our company s success. 
  • We demonstrate our commitment to our employees by offering a competitive and valuable rewards program.
  • Our company s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives


  
Job Segment:  Biochemistry, Biotech, Law, Project Manager, Animal Health, Science, Legal, Technology, Veterinary                       

Locations

Oss NL

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